Drugs

Some Tasigna Patients May be Able to Stop Treatment: FDA

FDA says it has updated the labeling for Novartis’ cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients. An agency news release says Tasigna was approved in 2007 and is indicated for treating patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).

The updated labeling says that patients with chronic-phase CML who have been taking Tasigna for three years or more and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization may be eligible to stop taking Tasigna.

Information about discontinuing Tasigna was based, the release says, on two single-arm trials of patients with Ph+ chronic phase CML. The trials measured how long patients were able to stop taking Tasigna without the leukemia returning. In the first trial, FDA says, among the 190 newly diagnosed patients with CML who stopped taking Tasigna after taking it for three years or more, 51.6% were in treatment-free remission after 48 weeks and 48.9% were still in remission after 96 weeks. In the second trial, among the 126 patients who stopped taking Tasigna after taking it for three years or more after switching from the cancer drug imatinib (Novartis’ Gleevec), 57.9% were in treatment-free remission about 48 weeks and 53.2% after 96 weeks.

Common side effects in patients who discontinued Tasigna included musculoskeletal symptoms such as body aches, bone pain, and pain in extremities.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome